验证业务和计算机化系统验证

2022-12-26 · 法默康

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验证业务和计算机化系统验证封面图

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验证咨询服务内容包括:

Verification consulting services include:

1.培训:提供完善的验证专题培训,包括如何编制URS、SIA\CCA风险评估、各种设备如何验证、检验方法验证培训、清洁验证培训、计算机验证以及工艺验证培训等,具体培训课题可见培训业务板块介绍。

1. Training: provide complete verification training, including how to prepare URS, SIA CCA risk assessment, how to verify various equipment, inspection method verification training, cleaning verification training, computer verification and process verification training. See the introduction of training business section for specific training topics.

2.编制:编制/指导编制URS、SIA\CCA文件以及、各类验证方案/报告等等

2. Preparation: prepare/guide the preparation of URS, SIA CCA documents and various verification schemes/reports, etc

3.实施:实施/指导实施设施设备验证、检验方法验证、清洁验证、计算机验证、工艺验证等

3. Implementation: implement/guide the implementation of facilities and equipment validation, inspection method validation, cleaning validation, computer validation, process validation, etc

验证咨询服务方式:

Verification consulting service mode:

指导式服务:客户与我们相互合作,我们提供方法、理念并指导客户实施,客户接受方法、理念并实施。

Guided service: customers cooperate with us. We provide methods and concepts and guide customers to implement them. Customers accept methods and concepts and implement them.

“交成果”式服务:由我公司服务验证文件的编制,客户按我公司的文件进行实施。

"Deliverable" service: the preparation of service verification documents by our company, and the implementation of the customer according to our company's documents.

计算机化系统验证服务:

Computerized system verification service:

北京齐力佳计算机(化)系统验证咨询团队为您提供符合CFDA、EUGMP、美国FDA的计算机(化)系统咨询、验证服务。服务内容包括:

Beijing Qilika Computer (Chemical) System Verification Consulting Team provides you with computer (chemical) system consulting and verification services that comply with CFDA, EUGMP and FDA. Services include:

计算机化系统差距分析;

Computerized system gap analysis;

计算机化系统管理体系建设;

Construction of computerized system management system;

指导编写各类GXP相关的计算机(化)系统验证文件;

Guide the preparation of various GXP related computer (chemical) system verification documents;

提供符合GAMP5的全套验证方案,持续满足FDA、EU等的要求,从用户需求、验证计划、质量&项目计划、IQ、OQ、验证总结报告等。

Provide a full set of verification schemes in line with GAMP5, continuously meet the requirements of FDA, EU, etc., from user requirements, verification plan, quality&project plan, IQ, OQ, verification summary report, etc.

以上就是为大家介绍的有关计算机化系统验证公司的详细的介绍,希望对您有所帮助.如果您有什么疑问的话,欢迎联系我们.我们将以的态度,为您提供服务https://www.fmkgmp.com

The above is a detailed introduction to the computerized system validation company, and we hope it will be helpful to you. If you have any questions, please contact us. We will provide services for you with our attitude https://www.fmkgmp.com